Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03148210
Previous Study | Return to List | Next Study

Undiagnosed COPD and Asthma Population Study (UCAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03148210
Recruitment Status : Enrolling by invitation
First Posted : May 10, 2017
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE May 8, 2017
First Posted Date  ICMJE May 10, 2017
Last Update Posted Date March 1, 2021
Actual Study Start Date  ICMJE June 5, 2017
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2017)
Annual rate of patient initiated healthcare utilization events for respiratory illness [ Time Frame: 12 months ]
Number of visits for respiratory illnesses divided by the length of time in the study
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
Rate of unscheduled healthcare utilization events for respiratory illness [ Time Frame: 12 months ]
Number of unscheduled visits
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Undiagnosed COPD and Asthma Population Study (UCAP)
Official Title  ICMJE A Randomized, Controlled, Clinical Trial to Address the Burden of Undiagnosed Airflow Obstruction in Canadian Adults
Brief Summary Previous population health studies suggest that up to 10% of Canadian adults have undiagnosed asthma or COPD- these people are currently undiagnosed and untreated, even though they may have significant respiratory symptoms. Our study will use targeted casefinding to find people with undiagnosed asthma and COPD in Canadian communities. The investigators will assess their symptoms and their health care use and number of sick days to determine the burden of undiagnosed respiratory disease in these people. The investigators will then determine whether early treatment of previously undiagnosed airflow obstruction will improve patients' health outcomes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • COPD
Intervention  ICMJE
  • Drug: Treatment strategy using evidence-based guidelines for asthma or COPD
    The respirologist will determine the clinical extent of the patient's symptoms, activity limitation, and degree of airflow obstruction and will commence the subject on asthma or COPD medications if indicated
  • Behavioral: Smoking Cessation
    Smoking cessation counselling by a qualified educator if currently smoking
  • Behavioral: Participant Education
    Standardized education for asthma or COPD disease
Study Arms  ICMJE
  • Active Comparator: Enhanced Care
    Treatment strategy using evidence-based guidelines for asthma or COPD
    Interventions:
    • Drug: Treatment strategy using evidence-based guidelines for asthma or COPD
    • Behavioral: Smoking Cessation
    • Behavioral: Participant Education
  • Placebo Comparator: Standard of Care
    Spirometry result sent to family MD
    Intervention: Behavioral: Smoking Cessation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 8, 2017)
550
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects at least 18 years old;
  • Subjects who score > or = to 6 points on The Asthma Screening Questionnaire or > 19.5 points on The COPD Diagnostic Questionnaire;
  • Subjects who have given written informed consent to participate in this trial in accordance with local regulations;
  • Subjects able to perform pre and post bronchodilator spirometry to measure lung function;

Additional Inclusion Criteria for RCT:

Those subjects who have undiagnosed airflow obstruction (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose FEV1 improves by > 12% and 200 ml after bronchodilator and COPD will be diagnosed in subjects who do not have a significant bronchodilator response and who exhibit persistent airflow obstruction post bronchodilator) will be asked to consent and participate in the RCT.

Exclusion Criteria:

  • Subjects who report a previous physician diagnosis of asthma.
  • Subjects who report a previous physician diagnosis of COPD
  • Subjects with any of the following conditions within the past 3 months: Heart attack or hospitalization for other heart problems; Stroke; Aortic or cerebral aneurysm; Detached retina or eye surgery
  • Subjects who are in the third trimester of pregnancy
  • Subjects involved in another interventional trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03148210
Other Study ID Numbers  ICMJE 20170182-01H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ottawa Hospital Research Institute
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP